EHR, Validation & Clinical Source Data Integrity

Written by Daemon Lincoln, Cmed Head of Compliance

Attendance at a recent event on Electronic Source Data (1) (eSource) confirmed that data held within Electronic Health Record and Electronic Medical Record (EHR / EMR) Systems are increasingly being used as the source for clinical trials. This practice imposes stringent requirements upon those EHR / EMR Systems; requirements that may not have been considered at the time of their original development, procurement and implementation.

Clinical research regulations require that all data collected as part of a clinical trial has a high degree of assured integrity. This can be expressed by stating that the data must have been collected and managed according to the principles of Good Clinical Practice (GCP) ALCOA+ (2). This requires data governance and technical measures be in place which ensure that the data is Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent and Enduring. In addition, the evidence confirming that all of the above standards can be met must be readily available in order for the data to be included in a clinical study. In terms of EHR / EMR, the System(s) must be appropriately validated*.

The requirement for EHR / EMR Systems to be validated is currently one of the principal causes of difficulty for Sponsors attempting to qualify research Sites for inclusion into a clinical trial. Looking in more detail, what exactly are some of the key requirements that would need to be in place for an EHR / EMR system to be considered validated and suitable for managing clinical source data?

  • Developed in compliance with industry best practices (3)
  • Access restricted to appropriately authorised individuals
  • Ability to output complete and accurate records
  • Suitable secure, reviewable audit trail (4)
  • Controls over System date/time to ensure timestamp accuracy
  • Documented training records for System Users, Maintainers and Developers
  • Periodically verified backup and restore procedures

Confirmation of the above (and more) is currently being managed by the Sponsor or CRO Clinical Research Associates (CRAs) visiting Sites, which means multiple interactions with Site Coordinators, local Site IT and System Vendors, many of whom have only limited experience with Good Clinical Practice expectations. The process and end result is generally unsatisfactory and often results in a number of workarounds being imposed upon the Site. This can include exclusion of the use of the EHR / EMR System(s) for the management of study source data, meaning that historical medical records must be printed out and any study related data must be captured to paper. This is clearly not the Industry Regulator’s envisioned future of smart, electronic-based clinical trials. The availability of GCP compliant EHR / EMR Systems which can be successfully interfaced to clinical data capture systems is likely to become the answer in due time, but it is not the practical reality of today.

For an alternative approach to the collection and management of study source data see Cmed’s encapsia Clinical Data Suite pages; these describe a new generation, validated solution that has been designed for rapid, compliant and effective management of clinical data.

* Validated – implemented and managed to assure effective and consistent intended performance in order to ensure subject safety and clinical data integrity.


References

1. Research Quality Assurance – eSource (4th April 2017, London, UK)
2. Guidance on Good Data and Record Management Practices. WHO Technical Report, No. 996, Annex 5, 2016.
3. GAMP 5 – A Risk-Based Approach to Compliant GXP Computerised Systems, ISPE GAMP Forum, 2008.
4. 21 CFR 11 – Electronic Records; Electronic Signatures; Final Rule, US Food and Drug Administration, 1997.